FDA 510(k) Applications for Medical Device Product Code "DSP"
(System, Balloon, Intra-Aortic And Control)

FDA 510(k) Number Applicant Device Name Decision Date
K062582 ABIOMED, INC. SUPRACOR BALLOON CATHETER 12/14/2006
K070225 ABIOMED, INC. SUPRACOR INTR-AORTIC BALLOON PUMP CONSOLE 12/13/2007
K864994 ARIES MEDICAL, INC. 40CC PER. PRE-FURL (S/L) INTRA-AORTIC CATHETER 06/19/1987
K864567 ARIES MEDICAL, INC. 40CC PERCUTANEOUS FURL DOU. LUMEN BALLOON CATHETER 05/12/1987
K863185 ARIES MEDICAL, INC. 40CC PERCUTANEOUS FURL SINGLE INTRA-AORTIC BALLOON 01/16/1987
K864537 ARIES MEDICAL, INC. 40CC PERCUTANEOUS PRE-FURL (D/L) BALLOON CATHETER 06/19/1987
K864568 ARIES MEDICAL, INC. 40CC SURGICAL DOUBLE LUMEN BALLOON CATHETER 05/12/1987
K895433 ARIES MEDICAL, INC. ARIES 30CC & 50CC INTRA-AORTIC BALLOON & CONT. SYS 04/10/1990
K833632 ARIES MEDICAL, INC. ARIES MEDICAL MODEL 700 05/16/1984
K844220 ARIES MEDICAL, INC. ARIES MEDICAL PERFLEX PERCUTANEOUS 40CC D/L BALLOO 02/20/1985
K162820 ARROW INTERNATIONAL, INC. AC3 Series IABP System 03/31/2017
K963865 ARROW INTL., INC. 8 FR. -30CC NARROWFLEX SHEATHLESS INTRA-AORTIC BALLOON CATHETER, PRODUCT NUMBER IAB-04830S 09/16/1997
K963920 ARROW INTL., INC. 8 FR.-30CC NARROWFLEX INTRA-AORTIC BALLOON CATHETER, 06/17/1997
K960713 ARROW INTL., INC. 8 FR.-40CC ARROW FLEX INTRA-AORTIC BALLOON CATHETER WITH BLUE FLEX TIP, PRODUCT NUMBER IAB-04840(USED WITH A 9FR.SHEATH) 05/15/1996
K993966 ARROW INTL., INC. 8FR. NARROWFLEX UNIVERSAL INTRA-AORTIC BALLOON CATHETER 02/18/2000
K963104 ARROW INTL., INC. 9.5 FR.- FLEXI-CATH INTRA-AORTIC AND CONTROL SYSTEM 02/04/1997
K965209 ARROW INTL., INC. ACAT 1 (ARROW CARDIAC ASSIST TECHNOLOGY 1) 01/23/1998
K002256 ARROW INTL., INC. ARROW ACAT 2 INTRA-AORTIC BALLOON PUMP 05/03/2001
K021462 ARROW INTL., INC. ARROW INTRA-AORTIC BALLOON (IAB) CATHETER WITH A FIBER OPTIC SENSOR AND A MEASUREMENT SYSTEM, MODELS IAB-05830-F,IAB5840 06/06/2002
K945230 ARROW INTL., INC. ARROW KINK RESISTANT FLEXI-CATH INTRA-AORTIC BALLOON 05/09/1995
K010330 ARROW INTL., INC. ARROW REDIGUARD, 9FR. 50CC, INTRA-AORTIC BALLOON VATHETER, IAB-R950-U 03/02/2001
K961358 ARROW INTL., INC. ARROW SHEATHLESS INTRA-AORTIC BALLOON CATHETER 07/02/1996
K000729 ARROW INTL., INC. ARROW ULTRA 8 INTRA-AORTIC BALLOON CATHETERS (IABS) 8FR 30CC AND 40CC UNIVERSAL 05/19/2000
K060309 ARROW INTL., INC. AUTOCAT INTRA-AORTIC BALLOON PUMP SERIES 04/06/2006
K970689 ARROW INTL., INC. IAB-04840-U;IAB-04250-U;IAB-04240-U;IAB-04230-U 06/04/1998
K040801 ARROW INTL., INC. INTRA-AORTIC BALLOON (IAB) 05/06/2004
K790241 AVCO MEDICAL PRODUCTS INTRA-AORTIC BALLOON-PUMP 02/23/1979
K802924 AVCO MEDICAL PRODUCTS KONTRON PERCUTAEOUS DOUBLE-LUMEN 03/11/1981
K781848 AVCO MEDICAL PRODUCTS PUMP, BALLOON MODEL 10 01/23/1979
K770821 AVCO MEDICAL PRODUCTS PUMP, BALLOON, INTRA-AORTIC, TRI-SEGMENT 05/06/1977
K983866 BELMONT INSTRUMENT CORP. BELMONT MODEL NGPBP INTRA-AORTIC BALLOON PUMP 01/06/2000
K915580 BELMONT INSTRUMENT CORP. BELMONT MODEL PBP INTRA-AORTIC BALLOON PUMP 10/30/1992
K982538 BELMONT INSTRUMENT CORP. BELMONT PORTABLE BALLOON PUMP, BARD TRANSACT IABP 10/02/1998
K950687 BELMONT INSTRUMENT CORP. EXTERNAL HELIUM SUPPLY (ACCESSORY FOR IABP) 05/24/1995
K952576 BELMONT INSTRUMENT CORP. TRANSPORT CART 12/26/1995
K972113 BOSTON SCIENTIFIC CORP. 30 CC AND 40 CC SUB-9 NITINOL AND 30 AND 40 CC SUB-9 STAINLESS STEEL 09/02/1997
K974247 BOSTON SCIENTIFIC CORP. 40 CC GRANDE 02/10/1998
K971673 BOSTON SCIENTIFIC CORP. 40 CC SUMO 08/05/1997
K943919 BOSTON SCIENTIFIC CORP. 9.5 FR SENSATION DL INTRA-AORTIC BALLON CATHETER 03/23/1995
K926000 BOSTON SCIENTIFIC CORP. 9.5 FR SIDEWINDER DL INTRA-AORTIC BALLON CATHETER 08/30/1993
K952221 BOSTON SCIENTIFIC CORP. BSC/CA 30 & 40 SENSATION, MODELS 930 & 940 08/11/1995
K936232 BOSTON SCIENTIFIC CORP. BSC/CA MODEL 930 IAB, BSC/CA 30 SIDEWINDER 10/14/1994
K940298 BOSTON SCIENTIFIC CORP. BSC/CA MODEL 940 IAB 04/06/1995
K963187 BOSTON SCIENTIFIC CORP. MODIFIED LABELING OF CARDIAC ASSIST INTRA-AORTIC BALLOON CATHETERS: MODEL 930 - 940, 30 - 40 CC SENSATION AND NICATH 30C 11/04/1996
K954431 BOSTON SCIENTIFIC CORP. PERCUTANEOUS INTRA-AORTIC BALLOON CATHETERS 01/11/1996
K900281 BOSTON SCIENTIFIC CORP. SERIES 3001 IABP 04/19/1990
K894942 BOSTON SCIENTIFIC CORP. SIDEWINDER 40CC DL INTRA-AORTIC BALLOON CATHETER 09/26/1989
K896920 BOSTON SCIENTIFIC CORP. SIDEWINDER 40CC DL INTRA-AORTIC BALLOON CATHETER 03/06/1990
K896597 BOSTON SCIENTIFIC CORP. THE SIDEWINDER 40CC DL INTRA-AORTIC BALLOON CATH. 02/12/1990
K813023 BRENTWOOD INSTRUMENTS, INC. FUKUDA DENSHI CARDIMAX FK-11 12/02/1981
K981660 C.R. BARD, INC. BARD 8FR., 40CC. SHEATHLESS INTRA-AORTIC BALLOON CATHETERS, BAR 7FR., 30CC. SHEATHLESS INTRA-AORTIC BALLOON CATHETERS 10/16/1998
K973962 C.R. BARD, INC. BARD 9FR., 30CC REDIGUARD AND TAPERSEAL BALLOONS 02/19/1998
K980850 C.R. BARD, INC. BARD 9FR., 40CC. REDIGUARD AND TAPERSEAL INTRA-AORTIC BALLOONS 06/03/1998
K962177 C.R. BARD, INC. BARD TAPERSEAL INTRA-AORTIC BALLOON CATHETER & INTRODUCER KIT 09/04/1996
K924382 C.R. BARD, INC. BARD(R) INTRA AORTIC BALLOON 04/07/1993
K112372 CARDIAC ASSIST, MAQUET CARDIOVASCULAR LLC CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP 09/15/2011
K112327 CARDIAC ASSIST, MAQUET CARDIOVASCULAR LLC SENSATION(TM) PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES 09/09/2011
K780280 DATASCOPE CORP. BALLOON PUMP 03/15/1978
K163542 Datascope Corp. CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage Case 01/31/2017
K151254 DATASCOPE CORP. CARDIOSAVE Hybrid Intra-Aortic Balloon Pump 07/02/2015
K181122 Datascope Corp. CARDIOSAVE Intra-Aortic Balloon Pump 05/31/2018
K031636 DATASCOPE CORP. CS100 INTRA-AORTIC BALLOON PUMP, MODEL 0998-00-3013-XX 08/11/2003
K172305 Datascope Corp. CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump 10/12/2017
K821065 DATASCOPE CORP. DATASCOPE 10.5 FRENCH INTRA-AORTIC BAL 08/19/1982
K041281 DATASCOPE CORP. DATASCOPE 7.5FR. IAB CATHETER AND ACCESSORIES 06/07/2004
K850482 DATASCOPE CORP. DATASCOPE 8.5 FRENCH ELECTRODE INTRA-AORTIC BALLOO 08/22/1985
K980385 DATASCOPE CORP. DATASCOPE 8FR. CO-LUMEN 34 AND 40CC INTRA-AORTIC BALLOON CATHETERS FOR OPTIONAL SHEATHLESS INSERTION WITH ACCESSORIES 05/01/1998
K942454 DATASCOPE CORP. DATASCOPE 95 AND 97 IAB PUMP CONSOLE 02/24/1995
K031569 DATASCOPE CORP. DATASCOPE CA 40 8FR. IABS, MODEL 0684-00-04XX 06/10/2003
K063525 DATASCOPE CORP. DATASCOPE FIBER OPTIC PRESSURE SENSOR INTRA-AORTIC BALLOON CATHETER AND CS300 INTRA-AORTIC BALLOON PUMP CONTROL SYSTEM 01/05/2007
K944460 DATASCOPE CORP. DATASCOPE INTRA-AORTIC BALLOON WITH MODIFIED STAT GARD 12/09/1994
K821951 DATASCOPE CORP. DATASCOPE MODEL 83 IABP SYSTEM 12/21/1982
K813182 DATASCOPE CORP. DATASCOPE MODIFIED #82 IABP SYSTEM 03/31/1982
K964987 DATASCOPE CORP. DATASCOPE PERCOR STAT - DL 9.5 FR. 25 AND 40CC INTRA-AORTIC BALLOON FOR OPTIONAL SHEATHLESS INSERTION AND PERCOR STAT -0 03/17/1997
K903892 DATASCOPE CORP. DATASCOPE PERCOR STAT 8.5 FR 40CC INTRA-AORTIC BAL 10/19/1990
K903893 DATASCOPE CORP. DATASCOPE PERCOR STAT 9.5 FR 40CC INTRA-AORTIC BAL 10/19/1990
K903867 DATASCOPE CORP. DATASCOPE PERCOR STAT DL 10.5 FR 40CC 10/19/1990
K903930 DATASCOPE CORP. DATASCOPE PERCOR STAT DL 10.5 FR 50CC 11/16/1990
K904018 DATASCOPE CORP. DATASCOPE PERCOR STAT DL 9.5 FR 40CC INTRA-AOR BAL 10/19/1990
K904414 DATASCOPE CORP. DATASCOPE PERCOR STAT DL 9.5 FR40CC STERIL ETO GAS 10/22/1990
K903736 DATASCOPE CORP. DATASCOPE PERCOR STAT DL10.5 FR40CC IN AORTIC BAL 10/09/1990
K914802 DATASCOPE CORP. DATASCOPE PERCOR STAT DL9.5 FR34CC INTRA-AORT BALL 08/25/1993
K910997 DATASCOPE CORP. DATASCOPE PERCOR STAT INTRA-AORTIC BALLOON 11/05/1991
K980780 DATASCOPE CORP. DATASCOPE PERCOR STAT-DL 9.5 FR. 25, 34 AND 40CC INTRA-AORIC BALLOONS WITH ALTERNATE B MEMBRANE FOR OPTIONAL SHEATHLES 05/29/1998
K880289 DATASCOPE CORP. DATASCOPE PERCOR STAT-MIL 9.5 FR INTRA-AORTIC BALL 06/10/1988
K810297 DATASCOPE CORP. DATASCOPE PERCOR=DL DUAL-LUMEN INTRA 05/06/1981
K003598 DATASCOPE CORP. DATASCOPE PROFILE 8FR. ALT B IAB, 34CC, DATASCOPE PROFILE 8FR. ALT B IAB, 40CC, MODEL 0684-000319, 0684-00-0320 12/21/2000
K912629 DATASCOPE CORP. DATASCOPE SYSTEM 95 03/11/1992
K020257 DATASCOPE CORP. DATASCOPE'S 8FR. ALT B IAB; DATASCOPE'S PROFILE 8FR. ALT B IAB; DATASCOPE'S TRUE SHEATHLESS DL 9.5 FR. IAB; DATASCOPE'S 04/24/2002
K994157 DATASCOPE CORP. DATASCOPE'S 8FR. POLYMIDE 25CC,34CC AND 40CC IAB AND ACCESSORIES, MODELS 0684-00-0327, 06844-00-0328, 0684-00-0329 03/13/2000
K801601 DATASCOPE CORP. DATASCOPE/AVCO CONNECTOR 01/13/1981
K831397 DATASCOPE CORP. FRENCH INTRA-AORTIC 9.5 BALLOON ON KON 11/02/1983
K831235 DATASCOPE CORP. IABP #90 SYSTEM 02/08/1985
K893243 DATASCOPE CORP. INTRA AORTIC BALLOON 06/20/1989
K940231 DATASCOPE CORP. INTRA-AORTIC BALLOON FOR OPTIONAL SHEATHLESS INSERTION 09/13/1994
K961509 DATASCOPE CORP. INTRA-AORTIC BALLOON PUMP SYSTEM 97 MODIFIED 11/15/1996
K790775 DATASCOPE CORP. INTRA-AORTIC BALLOON, TYPE S 10/01/1979
K133074 DATASCOPE CORP. MEGA 8FR. 50CC AND SENSATION PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETERS AND ACCESSORIES 12/12/2013
K811372 DATASCOPE CORP. MODEL 84 TRANSPORT SYSTEM 08/03/1981
K002949 DATASCOPE CORP. MODIFICATION TO DATASCOPE PROFILE 8FR. IAB, 34CC; MODIFICATION TO DATASCOPE PROFILE 8FR. IAB, 40CC 10/20/2000
K013326 DATASCOPE CORP. MODIFICATION TO: DATASCOPE 8FR. POLYIMIDE ALT B IAB, 25CC, 34CC, 40CC, DATASCOPE INSERTION KIT FOR 8 FR, POLYIMIDE ALT B 11/02/2001
K831307 DATASCOPE CORP. PECOR 8.5 FRENCH IAB ON A DATASCOPE 11/02/1983
K820882 DATASCOPE CORP. PECOR, PERCOR-DL, 10.5 FRENCH W/SMEC 10/18/1982
K905663 DATASCOPE CORP. PEDIATRIC INTRA-AORTIC BALLOON CATHETERS 08/02/1993
K833828 DATASCOPE CORP. PERCOR 9.5 FR IAB ON DATASCOPE CO2 02/08/1985
K802167 DATASCOPE CORP. PERCOR DATASCOPE INTRA-AORTIC BALLOON 01/13/1981
K823342 DATASCOPE CORP. PERCOR INTRA-AORTIC BALLOON INSERTION 01/24/1983
K902057 DATASCOPE CORP. PERCOR STAT DL 8.5 FR 40CC IAB ONLY/LABELING CHANG 09/25/1990
K911000 DATASCOPE CORP. PERCOR STAT DL 8.5 FR 40CC INTRA-AORTIC BALLOON 08/25/1993
K903769 DATASCOPE CORP. PERCOR STAT DL 9.5 FR 34CC INTRA-AORTIC BALLOON 10/19/1990
K920427 DATASCOPE CORP. PERCOR STAT DL 9.5 FR 40CC INTRA-AORTIC BALLOON 08/03/1993
K896497 DATASCOPE CORP. PERCOR STAT-DL 8.5 FR INTRA-AORTIC BALLOON 08/17/1990
K896430 DATASCOPE CORP. PERCOR STAT-DL 9.5 FR & STAT-SL 8.5 FR INTRA-AORTI 02/05/1990
K905056 DATASCOPE CORP. PERCOR STAT-DL 9.5 FR W/OPT INSERT W/O INTRO SHEAT 06/11/1991
K960166 DATASCOPE CORP. PERCOR STAT-DL 9.5 FR. 34 & 40CC 04/24/1996
K940178 DATASCOPE CORP. PERCOR STAT-DL 9.5 FR.34CC & 40CC /PERCOR STAT-DL 10.5 FR.40CC & 50CC INTRA-AORTIC BALLOON MODIFICATION 08/09/1994
K913847 DATASCOPE CORP. SYSTEM 90 AND SYSTEM 90T 03/11/1992
K921638 DATASCOPE CORP. SYSTEM 90 INTRA-AORTIC BALLOON PUMP CONSOLE 02/10/1993
K863219 DATASCOPE CORP. SYSTEM 90 TRANSPORT 01/14/1987
K965236 DATASCOPE CORP. SYSTEM 96 INTRA-AORTIC BALLOON PUMP (IABP) 07/01/1997
K922235 DATASCOPE CORP. SYSTEM 97 04/27/1993
K091449 DATASCOPE CORP., CARDIAC ASSIST DIVISION DATASCOPE'S 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MODELS 0684,00-0498-01, 02 06/18/2009
K120868 DATASCOPE CORP., CARDIAC ASSIST DIVISION MEGA(TM) 7.5FR. 30CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MEGA(TM) 7.5FR. 40CC INTRA-AORTIC BALLOON CATHETER 04/20/2012
K122628 DATASCOPE CORP., CARDIAC ASSIST DIVISION SENSATION PLUS 7.5FR. 40CC INTRA-AORTIC BALLOON (IAB) CATHETER AND ACCESSORIES 09/06/2012
K855102 EQUILIBRATED BIO SYSTEMS, INC. MONARK 869 ERGOMETER 05/09/1986
K082746 INSIGHTRA MEDICAL, INC. ULTRA IABP CATHETER KIT, MODELS IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, IMU7F-20 01/12/2009
K830410 JEDMED INSTRUMENT CO. EK COMBI MSG-1 04/27/1983
K830411 JEDMED INSTRUMENT CO. MINISCOPE MS-2 04/27/1983
K892797 KONTRON INSTRUMENTS, INC. "10 FR PERCUTAN DOUBLE LUMEN INTRA-AORTIC BALLOON 09/20/1989
K892799 KONTRON INSTRUMENTS, INC. "8 FR PERCUTAN DOUBLE LUMEN INTRA-AORTIC BALLOON 09/20/1989
K892798 KONTRON INSTRUMENTS, INC. "9 FR PERCUTAN DOUBLE LUMEN INTRA-AORTIC BALLOON 09/20/1989
K882274 KONTRON INSTRUMENTS, INC. 10.5 FRENCH PERCUTANEOUS DOUBLE LUMEN INTRA-AORTIC 03/20/1989
K903344 KONTRON INSTRUMENTS, INC. 9.5 FR PERCUTANEOUS DB LUMEN 40CC FLEXI-CATH (TM) 01/15/1991
K882508 KONTRON INSTRUMENTS, INC. 9.5 FRENCH PERCUTANEOUS DOUBLE LUMEN BALLOON 03/20/1989
K892222 KONTRON INSTRUMENTS, INC. 9.5F PERCU DOUBLE LUMEN INTRA-AORTIC BALLOON 09/14/1990
K820166 KONTRON INSTRUMENTS, INC. ADAPTATION OF KANTRON 40 CC. PDLIAB 04/29/1982
K853062 KONTRON INSTRUMENTS, INC. INTRA-AORTIC BALLOON PUMP MODEL K2000 01/22/1986
K875036 KONTRON INSTRUMENTS, INC. INTRA-AORTIC BALLOON PUMP MODEL KAAT 05/18/1988
K874816 KONTRON INSTRUMENTS, INC. KONTRON INTRA-AORTIC BALLOON PUMP MODEL K2000 04/01/1988
K892878 KONTRON INSTRUMENTS, INC. KONTRON INTRA-AORTIC BALLOON PUMP MODEL K9000 09/13/1989
K860427 KONTRON INSTRUMENTS, INC. KONTRON INTRA-AORTIC BALLOON PUMP MODEL KAAT 05/07/1986
K905313 KONTRON INSTRUMENTS, INC. KONTRON INTRA-AORTIC BALLOON PUMP, MODEL KAAT II 06/19/1991
K925248 KONTRON INSTRUMENTS, INC. MODIFICATION OF INTRA-AORTIC BALLOON CATHETERS 09/27/1993
K932268 KONTRON INSTRUMENTS, INC. MODIFICATIONS TO INTRA-AORTIC BALLOONS 12/15/1993
K860638 KONTRON INSTRUMENTS, INC. NOVEMPERC DOUBLE LUMEN INTRA-AORTIC BALLOON 10/01/1986
K903917 PPG HELLIGE B.V. COMPACT MONITOR SMK 210,211,230,231,240 01/18/1991
K823739 SMEC, INC. INTRA-AORTIC BALLOON SYSTEM 02/18/1983
K813355 SMEC, INC. MODIFICATION OF THE PERCUTAN-BALLOON 07/02/1982
K840037 SMEC, INC. MODIFIED SMEC PERCUTANEOUS INTRA-AORTIC 02/01/1985
K832753 SMEC, INC. PERCUTANEOUS BALLOON 10/13/1984
K840367 SMEC, INC. PRESSURE TRIGGER MOD OF SMEC INTRA-AORT 12/11/1985
K790755 SMEC, INC. SMEC BALLOON CANNULA 05/14/1980
K823177 SMEC, INC. SMEC BALLOON SYSTEM 12/15/1982
K935184 ST. JUDE MEDICAL, INC. REDIFURL AND TEPERSEAL DL INTRA-AORTIC BALLOON CATHETERS WITH HYDROMER COATING 02/10/1995
K760695 YEHUDA TAMARI TAMARI-KAPLITT 10/06/1976


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